Clincosm LogoSign in Get a demo

Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study

Sponsor
International Islamic University, Islamabad (Other)
Overall Status
Completed
CT.gov ID
NCT04179747
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
6.1
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Psychotherapy
  • Drug: Sildenafil Citrate 50Mg Tab
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
A Comparison of Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
Actual Study Start Date :
Jan 18, 2018
Actual Primary Completion Date :
Jul 24, 2018
Actual Study Completion Date :
Jul 24, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

The cognitive behavior psychotherapy was administered to participants in this treatment arm.

Behavioral: Cognitive Behavioral Psychotherapy
The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.
Other Names:
  • Cognitive Behavior Psychotherapy

    		•
    Active Comparator: Control Group

    This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction.

    Drug: Sildenafil Citrate 50Mg Tab
    The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.
    Other Names:
  • PDE5i

    		•

    Outcome Measures

    Primary Outcome Measures

    1. International Index of Erectile Functioning-5 [3 months maximum]

      The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.

    Secondary Outcome Measures

    1. Depression, Anxiety, and Stress Scale-21 [3 months maximum]

      The scale has three sub-scales. Depression sub scale, Minimum Score: Zero; Maximum Score: 42 Anxiety sub scale, Minimum Score: Zero; Maximum Score: 42 Stress sub scale, Minimum Score: Zero; Maximum Score: 42 The lowest scores on each of the sub scales indicate better functioning, the higher scores on each sub scale indicate a worse outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 39 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Men diagnosed with erectile dysfunction

    2. Must be in the age range of 18 to 39 years

    3. Must be in a stable heterosexual relationship

    4. Must not be suffering from any medical or psychiatric illness

    Exclusion Criteria:

    1. Men not meeting criteria of diagnosis of erectile dysfunction

    2. Men not in a heterosexual relationship

    3. Men of or above the age of 40 years

    4. Men diagnosed with any medical or psychiatric illness or obese men

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmad Bilal Private Practice Bahāwalpur South Punjab Pakistan 63100

    Sponsors and Collaborators

    • International Islamic University, Islamabad

    Investigators

    • Principal Investigator: Ahmad Bilal, MPhil, International Islamic University, Islamabad, Pakistan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmad Bilal, Principal Investigator, PhD Research Candidate, International Islamic University, Islamabad
    ClinicalTrials.gov Identifier:
    NCT04179747
    Other Study ID Numbers:
    • 0925-0585
    First Posted:
    Nov 27, 2019
    Last Update Posted:
    Nov 29, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmad Bilal, Principal Investigator, PhD Research Candidate, International Islamic University, Islamabad
    Sexual Dysfunctions, Men Health
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Sildenafil Citrate

    Study Results

    No Results Posted as of Nov 29, 2019